Publications by authors named "Xavier Roblin"

Background: There is a need for efficacious therapies for patients with Crohn's disease that are better tolerated and more durable than available treatments. We aimed to evaluate the efficacy and safety of filgotinib, an oral Janus kinase 1 preferential inhibitor, for treating Crohn's disease.

Methods: This phase 3, double-blind, randomised, placebo-controlled trial was conducted in 371 centres in 39 countries.

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Background: Therapeutic drug monitoring of infliximab is commonly performed based on trough concentration. However, doses and dosing intervals may be adapted to patient outcomes, and this trough concentration target may correspond to a large range of exposures in terms of the area under the concentration-time curve (AUC). The objectives of this study were to assess the real-life exposure to intravenous infliximab in patients with Crohn disease in remission at year 1 and to assess the evolution of exposure in patients who switched to subcutaneous infliximab.

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Background: Approximately half of patients with Crohn's disease require ileocolonic resection. Of these, 50% will subsequently have endoscopic disease recurrence within 1 year. We aimed to evaluate the efficacy and safety of vedolizumab to prevent postoperative recurrence of Crohn's disease.

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Objective: The Endoscopic Retrograde Cholangiopancreatography (ERCP) is the treatment of choice for biliary obstruction but is associated with post-ERCP pancreatitis (PEP) in around 5 % of cases. No radiological criteria have been evaluated for predicting PEP risk.

Design: This retrospective study examined records of 1365 patients who underwent ERCP at our center between 2014-2023.

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Article Synopsis
  • Therapeutic Drug Monitoring (TDM) is crucial for managing inflammatory bowel disease (IBD) patients on infliximab (IFX) or adalimumab, especially when there's a loss of response to these treatments; however, TDM isn't recommended for other biologic therapies.
  • A review of literature indicates that TDM might be beneficial for IFX subcutaneous (SC) use, while it's not effective for golimumab, and findings on vedolizumab are inconsistent; ustekinumab shows some promise, but less so than anti-TNF agents.
  • Recent advancements suggest that using dashboard systems for precision dosing of anti-TNF agents could optimize treatment, emphasizing a proactive approach to TDM.
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  • Biosimilars like CT-P17 offer cost-effective treatment options for patients with inflammatory bowel diseases (IBD) and chronic inflammatory rheumatic diseases (CIRD), but patient beliefs about these treatments can impact their adherence to switching.
  • This study involved 232 adult patients who transitioned to CT-P17 from either a low-concentration biosimilar or the reference adalimumab to gauge their treatment satisfaction and experiences over three months.
  • Results showed that satisfaction remained stable overall, but significantly more patients switching from a low-concentration biosimilar reported increased satisfaction compared to those switching from the reference product.
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Background/aims: Obtaining and maintaining corticosteroid-free remission are important goals of treatment for ulcerative colitis (UC). Characteristics associated with achieving corticosteroid-free remission were assessed in filgotinib-treated patients in SELECTION, a 58-week, phase 2b/3 trial in moderately to severely active UC.

Methods: This post hoc analysis used data from filgotinib-treated patients receiving corticosteroids at maintenance baseline in SELECTION.

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Background: There are limited data regarding therapeutic drug monitoring (TDM) of non-anti-tumor necrosis factor therapy in inflammatory bowel disease (IBD). This study aimed to evaluate the efficacy of proactive TDM in IBD patients treated with intravenous (iv) vedolizumab (VDZ).

Methods: This single-center retrospective cohort study included consecutive IBD patients treated with maintenance iv VDZ therapy undergoing TDM from November 2016 to March 2023.

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: Corticosteroids used to induce a response in Crohn's disease (CD) and ulcerative colitis (UC) may cause adverse reactions. The DICE study aimed to quantify and investigate factors associated with their use. : This cross-sectional, non-interventional study conducted in seven countries allowed us to collect data on oral corticosteroid exposure and excessive use (cf.

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Background & Aims: The aim of this study was to assess the long-term effectiveness and safety of risankizumab maintenance treatment in a large real-world cohort of patients with Crohn's Disease (CD).

Methods: From May 2021 to August 2023, all consecutive patients with CD treated with risankizumab in 25 GETAID centers have been retrospectively included. The primary endpoint was steroid-free clinical remission (Harvey Bradshaw Index [HBI] <5) at 52 weeks.

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Links between the gut microbiota and human health have been supported throughout numerous studies, such as the development of neurological disease disorders. This link is referred to as the "microbiota-gut-brain axis" and is the focus of an emerging field of research. Microbial-derived metabolites and gut and neuro-immunological metabolites regulate this axis in health and many diseases.

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Risankizumab (RZB) is a monoclonal antibody that targets the p19 subunit of interleukin (IL)-23. The ADVANCE and MOTIVATE randomized controlled trials (RCTs) demonstrated that intravenous (IV) RZB compared with placebo led to higher rates of clinical remission and endoscopic response at week 12 in patients with active Crohn's disease (CD). The phase III FORTIFY RCT showed that subcutaneous (SC) RZB was significantly more effective than placebo for achieving clinical remission and endoscopic response as maintenance therapy in patients with moderate-to-severe active CD.

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Background: While indirect comparison of infliximab (IFX) and vedolizumab (VDZ) in adults with Crohn's disease (CD) or ulcerative colitis (UC) shows that IFX has better effectiveness during induction, and comparable efficacy during maintenance treatment, comparative data specific to subcutaneous (SC) IFX (i.e., CT-P13 SC) versus VDZ are limited.

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Background: Several studies have reported low levels of physical activity (PA) in patients with inflammatory bowel diseases (IBD), possibly related to a lack of information and support, despite the many recognized benefits such as cardiovascular prevention or quality of life (QoL) improvement.

Methods: The purpose of our study was to identify challenges faced by patients and to evaluate IBD impact on PA and QoL by using the International Physical Activity Questionnaire short form and the 32-item Inflammatory Bowel Disease Questionnaire (IBDQ-32) questionnaire, respectively. We also assessed the expectations and knowledge of patients and healthcare professionals using the MICI-Active questionnaire that we developed.

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Article Synopsis
  • Data on the long-term effects of drug exposure during pregnancy on childhood development is limited and varies based on exposure duration and maternal drug levels.
  • Therapeutic drug monitoring during pregnancy can help manage drug exposure in mothers with inflammatory bowel disease (IBD) while ensuring effective treatment.
  • Anti-TNFα therapies, like adalimumab (ADA) and infliximab (IFX), have been found relatively safe during pregnancy, with low concentrations in breast milk, allowing for continued breastfeeding; however, more research is needed on other drugs like ustekinumab and vedolizumab.
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Background: While the efficacy of tofacitinib to induce and maintain clinical and endoscopic remission is well established in ulcerative colitis (UC), little is known about its efficacy to induce histological remission.

Methods: We conducted a retrospective multicentric cohort study. UC patients ≥ 16 years treated by tofacitinib in whom histological activity has been evaluated before and after induction were eligible.

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  • The study investigated the relationship between adalimumab (ADA) drug levels and Crohn's disease (CD) activity in patients who experienced a loss of response and underwent dose intensification.
  • It analyzed a group of 131 CD patients over five years, measuring ADA levels at critical points after the dose increase and assessing the impact on clinical and objective remission.
  • Findings indicate that higher ADA levels monitored at 6 and 12 months after dose-intensification are linked to improved remission rates, suggesting that post-treatment monitoring is more informative than initial baseline levels.
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Background: The relationship between subcutaneous infliximab [SC-IFX] concentrations and favourable therapeutic outcomes in patients with Crohn's disease [CD] and ulcerative colitis [UC] remains elusive.

Patients And Methods: This cross-sectional study included consecutive adult patients with inflammatory bowel disease [IBD] treated with SC-IFX at a maintenance dose of 120 mg/2 weeks. Investigated therapeutic outcomes included sustained clinical remission; composite clinical and biomarker remission [clinical remission and C-reactive protein <5 mg/L]; biochemical remission [faecal calprotectin <250 µg/g]; and deep remission [clinical, biological, and biochemical remission].

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Introduction: Extraintestinal manifestations (EIMs) of inflammatory bowel disease (IBD) are challenging clinical situation. No prospective study assessed remission risk factors of EIMs. The aim of this study was to prospectively investigate the epidemiology, risk factors of EIM occurrence, and EIM remission in a large IBD cohort.

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Background: In recent years, an increasing prevalence of obesity in inflammatory bowel disease (IBD) has been observed. However, only a few studies have focused on the impact of overweight and obesity on IBD-related disability.

Aims: To identify the factors associated with obese and overweight patients with IBD, including IBD-related disability.

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Unlabelled: Monitoring of anti-drug antibodies in patients on ustekinumab is not routinely recommended in patients with inflammatory bowel disease (IBD) due to low rates of immunogenicity.

Aim Of Study: The purpose of this study was to investigate the relationship between anti-drug antibodies detected by a drug-tolerant assay and loss of response (LOR) to therapy in a cohort of patients with IBD being treated with ustekinumab.

Patients And Methods: This retrospective study consecutively enrolled all adult patients with moderate to severe active IBD who had at least 2 years of follow-up after ustekinumab was initiated.

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Background: The effectiveness of anti-TNF or ustekinumab (UST) as a second-line biologic after vedolizumab (VDZ) failure has not yet been described.

Aims And Methods: In this retrospective multicenter cohort study, We aim to investigate the effectiveness of anti-TNF and UST as second-line therapy in patients with Crohn's disease (CD) who failed VDZ as a first-line treatment. The primary outcome was clinical response at week 16-22.

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